Prostate CancerP4NCT00692653
Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
A study testing P4 in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- P4
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven diagnosis of prostate cancer, stage I or II
- Diagnosis within the past 6 months
- Has appointment with a consulting specialist at one of the clinical trial sites
- Must be able to read and write English or Spanish at a 6th grade level
- Must not have begun any treatment (except watchful waiting)
- Must be able to complete baseline assessment before target clinician visit.
Who cannot join
- Advanced prostate cancer
- Diagnosed more than 6 months ago
- Cannot read and write English or Spanish at a 6th grade level
- Does not have appointment at one of the clinical trial sites
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
VA Medical Center / Medical College of Georgia
Augusta, Georgia, 30904
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Texas Health Sciences Center at San Antonio
San Antonio, Texas, 78229
Seattle Prostate Institute
Seattle, Washington, 98104
Veterans Administration Puget Sound Health Care System
Seattle, Washington, 98108
University of Washington Medical Center
Seattle, Washington, 98195
About this study
The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.
Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.
About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.
- Conditions
- Prostate Cancer
- Being tested
- P4
- Keywords
- Localized prostate cancer, Treatment decision making, Tailored decision aid
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P4Behavioural
Tailored online decision support system for prostate cancer treatment decision making
| Study group | Role | What they receive |
|---|---|---|
| P4 | Experimental | Participant uses P4 program before meeting with his clinician to discuss treatment options. Receives: Behavioral: P4 |
| Usual care+ | No intervention | Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
Measured: Baseline to 6 months
Decisional Satisfaction
Measured: Baseline to 6 months
Satisfaction with Preparation for Decision Making
Measured: Baseline to 1 month
Secondary outcomes (2)
Shift in decisional control preference from pre-decision to 1 month post-treatment
Measured: Baseline to 1 month
Resource utilization
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startFeb 2007
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Washington
- Responsible party
- Principal investigator, Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
- Investigators
- Seth Wolpin, RN, PhD, Principal investigator, University of WashingtonDonna L Berry, RN, PhD, Study director, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692653
- Sponsor's protocol ID
- 1R01NR009692
- Other IDs
- R01NR009692
- Acronym
- P4
- Status last verified
- Apr 2015
- First submitted
- 3 Jun 2008
- Last updated
- 4 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Underhill ML, Hong F, Berry DL. When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer. Health Qual Life Outcomes. 2014 Oct 25;12:159. doi: 10.1186/s12955-014-0159-3.
PubMed 25344101Bosco JL, Halpenny B, Berry DL. Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer. Health Qual Life Outcomes. 2012 Sep 28;10:123. doi: 10.1186/1477-7525-10-123.
PubMed 23021156Berry DL, Wang Q, Halpenny B, Hong F. Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer. Patient Educ Couns. 2012 Aug;88(2):262-7. doi: 10.1016/j.pec.2012.04.002. Epub 2012 May 17.
PubMed 22608696
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Patient Profile Prostate (P4) Randomized, Multisite Trial
- ClinicalTrials.gov ID
- NCT00692653
- Acronym / sponsor ID
- P4 / 1R01NR009692
- Conditions
- Prostate Cancer
- Keywords
- Localized prostate cancer, Treatment decision making, Tailored decision aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Washington
- Study start
- Feb 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether or not participation in an experimental program called the "P4 program" is useful to men who are faced with choices about treatment for their early stage prostate cancer. The P4 program consists of a series of questions and information for the participant.
Before seeing the cancer specialist, participants will answer several questionnaires on a computer. This will take about 20-30 minutes. Participants may choose to do this on a computer at home or on a touch-screen computer in the clinic. Half the participants will then be shown several highly rated informational websites about prostate cancer treatments. The other half, based on the individual participant's answers, will receive the P4 program's customized written and on-screen information. Reading the information and watching videos will take about 20 minutes.
About one month later, and again 6 months, participants will complete follow-up questionnaires electronically or by mail. These questionnaires will help us understand how each participant's decision for treatment of their prostate cancer went. Answering these questionnaires should take about 20 minutes each time.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P4 | Experimental | Behavioral: P4Participant uses P4 program before meeting with his clinician to discuss treatment options. |
| Usual care+ | No intervention | –Usual care plus participant is directed to reputable websites highly rated in research literature to learn more about prostate cancer treatments. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy-proven diagnosis of prostate cancer, stage I or II
- Diagnosis within the past 6 months
- Has appointment with a consulting specialist at one of the clinical trial sites
- Must be able to read and write English or Spanish at a 6th grade level
- Must not have begun any treatment (except watchful waiting)
Key exclusion criteria (4 listed)
- Advanced prostate cancer
- Diagnosed more than 6 months ago
- Cannot read and write English or Spanish at a 6th grade level
- Does not have appointment at one of the clinical trial sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P4Tailored online decision support system for prostate cancer treatment decision making | Behavioural | P4 |
Primary outcome
Decisional Conflict
Time frame: Baseline to 6 months
Decisional Satisfaction
Time frame: Baseline to 6 months
Satisfaction with Preparation for Decision Making
Time frame: Baseline to 1 month
2 secondary outcomes
Shift in decisional control preference from pre-decision to 1 month post-treatment
Time frame: Baseline to 1 month
Resource utilization
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Derived from this study: PubMed 25344101Underhill ML, Hong F, Berry DL. When study site contributes to outcomes in a multi-center randomized trial: a secondary analysis of decisional conflict in men with localized prostate cancer. Health Qual Life Outcomes. 2014 Oct 25;12:159. doi: 10.1186/s12955-014-0159-3.
- Derived from this study: PubMed 23021156Bosco JL, Halpenny B, Berry DL. Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer. Health Qual Life Outcomes. 2012 Sep 28;10:123. doi: 10.1186/1477-7525-10-123.
- Derived from this study: PubMed 22608696Berry DL, Wang Q, Halpenny B, Hong F. Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer. Patient Educ Couns. 2012 Aug;88(2):262-7. doi: 10.1016/j.pec.2012.04.002. Epub 2012 May 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seth Wolpin, RN, PhD principal investigator
University of Washington
Donna L Berry, RN, PhD study director
Dana-Farber Cancer Institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P4 in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Conflict (time frame: Baseline to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692653, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.